Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy
A Randomized, Double Blind, Placebo Controlled Phase 3 Trial of Immunotherapy With Autologous Antigen Presenting Cells Loading With PA2024 (Provenge(R), APC8015) in Men With Metastatic Androgen Independent Prostatic Adenocarcinoma
1 other identifier
interventional
512
2 countries
71
Brief Summary
Provenge is an investigational product designed to activate a man's own antigen presenting cells, a type of immune cell, so that they can detect prostate cancer cells and initiate an immune response against them. Having completed Phase 1 and Phase 2 clinical trials, Provenge is now at the Phase 3 level. One important Phase 3 trial of Provenge has been completed; the current trial is also a Phase 3 study. If you decide to participate and are eligible, you will be enrolled in the study and randomly assigned to receive either active product or placebo. There are two chances in three that you will receive Provenge. After receiving treatment, you will be monitored at regular intervals until the study endpoints are met. At the end of the trial, men who received placebo will have the opportunity to be treated with active product in another study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 prostate-cancer
Started Jul 2003
Typical duration for phase_3 prostate-cancer
71 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedFirst Submitted
Initial submission to the registry
July 23, 2003
CompletedFirst Posted
Study publicly available on registry
July 24, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedResults Posted
Study results publicly available
September 6, 2010
CompletedSeptember 6, 2010
September 1, 2010
5.5 years
July 23, 2003
May 28, 2010
September 2, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
Time from randomization until death due to any cause.
Event-driven timeframe. Final analysis at 331 events.
Secondary Outcomes (1)
Time to Objective Disease Progression
Analysis conducted at the time of overall survival analysis
Study Arms (2)
APC-Placebo
PLACEBO COMPARATORSipuleucel-T
ACTIVE COMPARATORInterventions
Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with a PAP-GM-CSF. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.
Each dose of APC-Placebo contains approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Dendreonlead
Study Sites (71)
South Orange County Urological
Laguna Hills, California, 92653, United States
LLUMC for Molecular Biology and Gene Therapy
Loma Linda, California, 92354, United States
USC Keck School of Medicine
Los Angeles, California, 90089-9178, United States
UCLA
Los Angeles, California, 90095-1738, United States
Comprehensive Cancer Center
Palm Springs, California, 982262, United States
Sutter Cancer Center
Sacramento, California, 95816, United States
Kaiser Permanente Medical Group
San Diego, California, 92120, United States
Sharp HealthCare
San Diego, California, 92123, United States
UCSF Cancer Center
San Francisco, California, 94115, United States
Rocky Mountain Cancer Center
Denver, Colorado, 80220, United States
Connecticut Urological Research at Grove Hill
New Britain, Connecticut, 06052, United States
Helen F. Graham Cancer Center
Newark, Delaware, 19713, United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20057, United States
Walter Reid Army Medical Center
Washington D.C., District of Columbia, 20307, United States
Miami Cancer Center
Miami, Florida, 33133, United States
Urology Center of South Florida
Miami, Florida, 33173, United States
Cancer Centers of Florida
Ocoee, Florida, 34761, United States
Hematology/Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, 34952, United States
Georgia Urology, P.A.
Atlanta, Georgia, 30342, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Midwest Prostate & Urology Health Center
Chicago, Illinois, 60640, United States
Loyola University
Maywood, Illinois, 60153, United States
Lutheran General Cancer Center
Park Ridge, Illinois, 60068, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Chesapeake Urology Associates
Baltimore, Maryland, 21204, United States
Myron I Murdock MD LLC
Greenbelt, Maryland, 20770, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115-6084, United States
Lahey Clinic (Department of Urology)
Burlington, Massachusetts, 01805, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Nevada Cancer Institute
Las Vegas, Nevada, 89135, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Associates in Urology, LLC
West Orange, New Jersey, 07052, United States
Albany Regional Cancer Center
Albany, New York, 12208, United States
The Urological Institute of Northeastern New York
Albany, New York, 12208, United States
North Shore Hematology Oncology Associates
East Setauket, New York, 11733, United States
New York Medical College
Hawthorne, New York, 10532, United States
Beth Israel Cancer Center
New York, New York, 10003, United States
New York University
New York, New York, 10016, United States
Clinical Cancer Center
New York, New York, 10029, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Staten Island Urological Research
Staten Island, New York, 10304, United States
McKay Urology
Charlotte, North Carolina, 28204, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
University of Cincinnati
Cincinnati, Ohio, 45267-0502, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
EACRI
Portland, Oregon, 97213, United States
Kaiser Permanente Medical Group
Portland, Oregon, 97227-1191, United States
Oregon Urology Specialists
Springfield, Oregon, 97477, United States
Center for Urologic Care
Bryn Mawr, Pennsylvania, 19010, United States
Jefferson Medical College
Philadelphia, Pennsylvania, 19107, United States
Grand Strand Urology
Myrtle Beach, South Carolina, 29572, United States
Mary Crowley
Dallas, Texas, 75246, United States
Urology Associates of North Texas
Fort Worth, Texas, 76104, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Urology of Virginia, PC
Norfolk, Virginia, 23502, United States
Urology of Virginia, PC
Norfolk, Virginia, 23507, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Cancer Care Northwest
Spokane, Washington, 99218, United States
Wenatchee Valley Medical Center
Wenatchee, Washington, 98801, United States
University of Wisconsin, Madison
Madison, Wisconsin, 53792, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
St. Luke's Hospital Immunotherapy Program
Milwaukee, Wisconsin, 53215, United States
Can-Med Medical Research, Inc.
Victoria, British Columbia, V8T 5G1, Canada
London Health Sciences Centre
London, Ontario, N6A 4G5, Canada
Urology CURC Scarborough
Scarborough Village, Ontario, M1S 4V5, Canada
Sunnybrook & Women's College HSC
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Hospital Notre Dame du CHUM
Montreal, Quebec, H2L 4M1, Canada
Related Publications (4)
Ju M, Fan J, Zou Y, Yu M, Jiang L, Wei Q, Bi J, Hu B, Guan Q, Song X, Dong M, Wang L, Yu L, Wang Y, Kang H, Xin W, Zhao L. Computational Recognition of a Regulatory T-cell-specific Signature With Potential Implications in Prognosis, Immunotherapy, and Therapeutic Resistance of Prostate Cancer. Front Immunol. 2022 Jun 23;13:807840. doi: 10.3389/fimmu.2022.807840. eCollection 2022.
PMID: 35812443DERIVEDSmall EJ, Higano CS, Kantoff PW, Whitmore JB, Frohlich MW, Petrylak DP. Time to disease-related pain and first opioid use in patients with metastatic castration-resistant prostate cancer treated with sipuleucel-T. Prostate Cancer Prostatic Dis. 2014 Sep;17(3):259-64. doi: 10.1038/pcan.2014.21. Epub 2014 Jun 24.
PMID: 24957547DERIVEDFlanigan RC, Polcari AJ, Shore ND, Price TH, Sims RB, Maher JC, Whitmore JB, Corman JM. An analysis of leukapheresis and central venous catheter use in the randomized, placebo controlled, phase 3 IMPACT trial of Sipuleucel-T for metastatic castrate resistant prostate cancer. J Urol. 2013 Feb;189(2):521-6. doi: 10.1016/j.juro.2012.09.029. Epub 2012 Dec 14.
PMID: 23253957DERIVEDKantoff PW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, Redfern CH, Ferrari AC, Dreicer R, Sims RB, Xu Y, Frohlich MW, Schellhammer PF; IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010 Jul 29;363(5):411-22. doi: 10.1056/NEJMoa1001294.
PMID: 20818862DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kathleen Picha
- Organization
- Dendreon Corporation
Study Officials
- STUDY CHAIR
Paul Schellhammer, MD
Devine Tidewater Urology
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 23, 2003
First Posted
July 24, 2003
Study Start
July 1, 2003
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
September 6, 2010
Results First Posted
September 6, 2010
Record last verified: 2010-09